Dedinje FFR/QFR Registry

Recruiting

• Conditions: Coronary Artery Disease (CAD); Fractional Flow Reserve

• Registration Number: NCT06659367
• Lead Sponsor: Institute for Cardiovascular Diseases Dedinje

Brief Summary

Quantitative Flow Ratio (QFR) has shown good diagnostic performance against Fractional Flow Reserve (FFR) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. However, the reproducibility of QFR is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 QFR procedure experience) are performing the analysis. Although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with FFR, the concern about the diagnostic performance of QFR in real-world clinical practice by inexperienced users remains.

The primary objective of "Dedinje FFR/QFR Registry" is to determine the feasibility and diagnostic performance of QFR analysis by vendor-certified inexperienced medical users in a real-world setting using FFR as the gold standard. All patients \>18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry. FFR procedure is performed according to the standardized institutional protocol. QFR analysis will be subsequently performed offline according to a standard operating procedure.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-02
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Primary Completion: 2029-10-02
• Study Completion: 2034-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• >18 years old
• Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)

Exclusion Criteria

• Declines to participate in the registry and provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)
Sensitivity of Quantitative Flow Ratio (QFR)	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Sensitivity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Specificity of Quantitative Flow Ratio (QFR)	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Specificity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Positive predictive value of Quantitative Flow Ratio (QFR)	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Positive predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Negative predictive value of Quantitative Flow Ratio (QFR)	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Negative predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard
Diagnostic gray zone	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Quantitative Flow Ratio (QFR) limits for achieving 95% sensitivity and specificity in comparison to Fractional Flow Reserve (FFR)
Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR)	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Area under the curve (using cutoff values of \<=0.80 for both methods)

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Sensitivity, specificity, positive predictive value and negative predictive value of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR)
Diagnostic accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Area under the curve (using cutoff values of \<=0.89 for nonhyperemic pressure ratios and \>=50% diameter stenosis for 3-dimensional Quantitative Coronary Angiography (3D-QCA)) against Fractional Flow Reserve (FFR, cutoff value \<=0.80)
Inter-observer variability	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Coefficient of variation for repeated Quantitative Flow Ratio (QFR) computation between users, standard deviation for repeated Quantitative Flow Ratio (QFR) measurements between users, binary diagnostic classification agreement between users
Intra-observer variability	at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)	Coefficient of variation for repeated Quantitative Flow Ratio (QFR) computation within users, standard deviation for repeated Quantitative Flow Ratio (QFR) measurements within users, binary diagnostic classification agreement within users
All-cause death	at 6 months, 1 year and annually for 5 years	All-cause death
Myocardial infarction	at 6 months, 1 year and annually for 5 years	Myocardial infarction
Vessel-oriented composite outcome	at 6 months, 1 year and annually for 5 years	Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization
Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months	6 months	Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months from the time of the Fractional Flow Reserve (FFR) procedure. (scale 0-100, 100 = full health, 0 = worst health)
Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score	6 months	Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score at 6 months from the time of the Fractional Flow Reserve (FFR) procedure (scale 5-25, 5= no problems in any dimension, 25= extreme problems on all dimensions; visual analogue scale 0-100, 0= worst health possible, 100= best health possible)

Trial Locations

Locations (1)

Institute for Cardiovascular Diseases "Dedinje"; 🇷🇸 Belgrade, Serbia